Drug recall
Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH…
FDA recall event 71994 · Class II · Bayer Healthcare
Key facts
| Event ID | 71994 |
|---|---|
| Recall numbers | Z-2775-2015 |
| Recalling firm | Bayer Healthcare |
| Product type | Devices |
| Products | Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position. |
| Initiation date | Aug 4, 2015 |
| Report date | Sep 23, 2015 |
| Termination date | Aug 17, 2016 |
| City | Indianola |
| State | PA |
| Country | United States |
| FEI number | 2520313 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: